Back to resultsWeekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study
Primary Purpose
Salivary Gland Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
docetaxel plus Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Salivary Gland Cancer
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed salivary gland cancer with one of the following histologic subtypes : mucoepidermoid, adenocarcinoma/ductal carcinoma or adenoid cystic carcinoma
Only progressive disease in case of ACC
Progressive disease is defined as one of the following occurring within 6 months of study entry (i) at least a 20% increase in radiologically or clinically measurable disease, (ii) appearance of new lesions or (iii) deterioration in clinical status
stage IV or recurrent cancer which is incurable with surgery or radiotherapy
age ≥ 20 years
ECOG performance status 0-1 ⑥ At least one measurable tumor lesion according to RECIST 1.1
Expected survival for approximately 12 weeks or longer
⑧ No prior systemic chemotherapy (Patients who received adjuvant chemotherapy or chemoradiotherapy completed more than 6 months before will be eligible)
- At least 4 weeks later after major surgery or radiotherapy ⑩ Organ function as evidence by the following; WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3; Total bilirubin ≤ 1.5 ULN AST/ALT ≤ 2.5 ULN, (if liver metastases: AST, ALT ≤5.0 x ULN); Creatinine clearance 50 mL/min or serum creatinine ≤ 1.5 x UNL ⑪ Written informed consent
Exclusion Criteria:
Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
- Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method) ④ Symptomatic CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed) ⑤ Patients with alcohol abuse
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cisplatin plus docetaxel
Arm Description
D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.
Outcomes
Primary Outcome Measures
Response rate
To evaluate the effectiveness of regimen. The overall response rate will be measured by RECIST v1.1.
Secondary Outcome Measures
Overall survival (OS)
Overal survival defined by date of all-cause mortality from date of IP administration will be calculated.
progression-free survival (PFS)
It is measure of the period of survival without disease progression.
Adeverse event(AE)
Adverse event will be evaluate using CTCAE V.4.0
Full Information
NCT ID
NCT05008237
First Posted
January 13, 2021
Last Updated
August 16, 2021
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05008237
Brief Title
Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study
Official Title
Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2014 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cisplatin plus weekly docetaxel as first-line chemotherapy in metastatic salivary gland cancer patients : a multicenter phase II study
Detailed Description
Preclinically, paclitaxel and docetaxel have demonstrated activity against salivary gland cancers1. Phase II trial of single-agent paclitaxel2, conducted by Eastern Cooperative Oncology Group in 45 patients with advanced SGC. Eight partial responses were observed among the 31 patients with mucoepidermoid carcinoma (MEC) or adenocarcinoma, but no responses were identified in the 14 patients with ACC. Based on its impressive anti-tumor activity in patients with head and neck cancer, especially in squamous cell carcinoma, Ragusa et al.3 evaluated the activity of docetaxel in 4 patients with high grade MEC of the major salivary glands. The treatment was well tolerated, and there was complete response in two and partial response in the other two patients.
However, myelosuppression is one of the serious concerns with every 3 week schedule of docetaxel administration, especially in older patients. Alternatively, a weekly dosing of docetaxel has been reported to reduce toxicity and Investigator previously reported weekly docetaxel and cisplatin chemotherapy in recurrent or metastatic nasopharyngeal cancer demonstrated high response rate with modest toxicities4. So Investigator planned this phase II study to evaluate the efficacy and safety of cisplatin plus weekly docetaxel in patients with metastatic salivary gland cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cisplatin plus docetaxel
Arm Type
Experimental
Arm Description
D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks
Treatment will be continued until disease progression or unacceptable toxic effects.
Intervention Type
Drug
Intervention Name(s)
docetaxel plus Cisplatin
Intervention Description
D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.
Primary Outcome Measure Information:
Title
Response rate
Description
To evaluate the effectiveness of regimen. The overall response rate will be measured by RECIST v1.1.
Time Frame
Up to 30months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overal survival defined by date of all-cause mortality from date of IP administration will be calculated.
Time Frame
The time until defineded by date of all-cause mortality from date of IP administration. Up to 30 months.
Title
progression-free survival (PFS)
Description
It is measure of the period of survival without disease progression.
Time Frame
The time until the date of either disease progression or the all cause mortality from the date of IP administration. Up to 30months.
Title
Adeverse event(AE)
Description
Adverse event will be evaluate using CTCAE V.4.0
Time Frame
from the date of informed consent signature to 21days after last drug administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed salivary gland cancer with one of the following histologic subtypes : mucoepidermoid, adenocarcinoma/ductal carcinoma or adenoid cystic carcinoma
Only progressive disease in case of ACC
Progressive disease is defined as one of the following occurring within 6 months of study entry (i) at least a 20% increase in radiologically or clinically measurable disease, (ii) appearance of new lesions or (iii) deterioration in clinical status
stage IV or recurrent cancer which is incurable with surgery or radiotherapy
age ≥ 20 years
ECOG performance status 0-1 ⑥ At least one measurable tumor lesion according to RECIST 1.1
Expected survival for approximately 12 weeks or longer
⑧ No prior systemic chemotherapy (Patients who received adjuvant chemotherapy or chemoradiotherapy completed more than 6 months before will be eligible)
At least 4 weeks later after major surgery or radiotherapy ⑩ Organ function as evidence by the following; WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3; Total bilirubin ≤ 1.5 ULN AST/ALT ≤ 2.5 ULN, (if liver metastases: AST, ALT ≤5.0 x ULN); Creatinine clearance 50 mL/min or serum creatinine ≤ 1.5 x UNL ⑪ Written informed consent
Exclusion Criteria:
Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method) ④ Symptomatic CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed) ⑤ Patients with alcohol abuse
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnamgu
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study
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